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Outsourcing in Clinical Trials New England
Meet Veristat at Outsourcing in Clinical Trials New England
Veristat is excited to participate in the 17th Annual...
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It was wonderful to connect with so many of our peers at RAPS Convergence 2025 in Pittsburgh. As the largest annual gathering of regulatory professionals, the event brought together more than 2,000 experts across pharmaceuticals, biologics, devices, and advanced therapies to share strategies for navigating today’s increasingly complex regulatory landscape.
This year’s agenda highlighted trends that directly impact sponsors preparing INDs, NDAs, BLAs, and global marketing applications. From expedited approval pathways and global harmonization to patient-centric trial design and lifecycle management, the conference reinforced how critical it is to approach submissions with foresight and integration.
Insight 1: Global Submissions Require Early, Integrated Planning 
Sessions on regulatory strategy and global harmonization stressed the importance of aligning early. Too often, sponsors defer submission planning until pivotal trial completion. This delay risks inconsistent data presentation, misaligned CTD modules, and regulatory queries that stall progress.
Integrated planning means engaging regulatory, biostatistics, and medical writing teams in parallel with trial design. The most successful sponsors unify data and messaging across geographies, ensuring that FDA, EMA, MHRA, and other health authorities see a cohesive submission package.
“At Veristat, we see the strongest programs treat submission planning as part of trial execution, not a separate phase. That’s how timelines stay intact and regulators gain confidence.” — Mandy McCormick, Business Development Manager.
Insight 2: IND Strategy Is Where Many Programs Stumble
IND strategy was a recurring theme, with sessions on clinical trial design, real-world evidence, pediatric trials, and precision medicine. These discussions highlighted that IND challenges often stem from overlooked stability data, GLP study requirements, or manufacturing documentation gaps.
“Every IND submission has potential pitfalls, but experienced teams know where they’re hidden. Early regulatory engagement prevents costly amendments and accelerates timelines.” — Alison Bawden, Senior Director, Regulatory Affairs
Sponsors that anticipate FDA questions and plan for advisory interactions are best positioned to avoid delays. Several speakers emphasized that an IND strategy should evolve dynamically as new data, endpoints, and patient input emerge.
Insight 3: Using Foreign Data in U.S. Submissions Is on the Rise
With global clinical trials expanding and FDA guidance on foreign data gaining attention, RAPS sessions focused on how sponsors can leverage multinational programs. The message was clear: foreign data is acceptable, but only if supported by rigorous compliance with GCP and ICH E3 standards.
Veristat has helped sponsors adapt foreign data for U.S. review, ensuring comparability with U.S. populations, mapping CSRs to regulatory expectations, and addressing missing elements such as investigator disclosures.
Insight 4: Patient-Centric Development and Rare Diseases Remain a Priority
Patient-focused drug development was front and center at RAPS 2025, with sessions on diverse enrollment, rare diseases, and N-of-1 trial designs. Regulators continue to expect sponsors to demonstrate not only efficacy and safety, but also patient relevance.
For sponsors working in rare and ultra-rare conditions, this means early engagement with regulators on trial design, patient-reported outcomes, and real-world evidence to strengthen submissions. The importance of transparent communication with both patients and agencies was underscored throughout the conference.
Insight 5: Regulators Expect Lifecycle Thinking
Another strong theme was lifecycle management and post-market commitments. From pharmacovigilance systems to risk management planning, regulators emphasized that approval is not the finish line, it’s the transition into long-term responsibility.
Sponsors who anticipate post-approval requirements during submission planning are better prepared to maintain compliance, fulfill commitments, and sustain product availability for patients. This requires cross-functional planning between regulatory, clinical, safety, and commercial teams well before the first approval letter is issued.
Shaping Submissions That Stand Up to Scrutiny
RAPS Convergence 2025 reinforced what we emphasize daily at Veristat: submission success comes down to early planning, integrated expertise, and proactive regulatory engagement.
Sponsors who anticipate complexity, embrace global harmonization, and incorporate patient and lifecycle perspectives will be best positioned to meet regulators’ expectations and deliver therapies to patients faster.
If you couldn’t join us in Pittsburgh, we invite you to explore our resource on 10 Keys to Success in Global Marketing Applications: a practical guide to planning smarter submissions, avoiding pitfalls, and accelerating approvals.